Validation Specialist

Role & responsibilities

• Responsible for execution of SAT, installation, operational and performance qualification equipment's & instruments.
• Responsible for execution of qualification activities related to thermal validation i.e. Steam sterilizer, vessels/tank system, Lyophilizer and tunnel etc.
• Responsible for equipment qualification i.e. filling & sealing m/c, vial washing, external vial washing m/c, HVAC, Isolators, VHP process, LAFs & dynamic pass boxes etc.
• Responsible for execution of temperature mapping activity for area and equipments.
• Responsible for compilation of documents during and / or after execution of any qualification / validation activity.
• Responsible for co-ordination and planning of qualification / validation activities.
• Responsible for compliance of validation schedule / planner and to ensure that, equipment qualification should be completed within due date.
• Responsible for preparation and /or review of validation master plan and site master file.
• Responsible for preparation and / or review of qualification / validation protocols and reports in complies with current guide lines.
• Responsible for preparation of SOP relate to QA validation policy / activities.
• Responsible for preparation and / or review of media fill protocol.
• Responsible for review of media fill interventions trend data.
• To involve in media fill simulation activities and responsible for compilation & preparation of media fill report.
• To involve / participate in investigation during failure / discrepancies related to qualification / validation (if any).
• Responsible for review of relevant documentation, i.e. logs books, calibration records, preventive maintenance records etc.
• To ensure engineering assurance at site.
• Responsible for review of (CSV) computer system validation documents with compliance of current regulatory requirements.
• To update and review of periodic qualification planner / schedule.
• Responsible for initiation and completion of QMS documents.
• Responsible for completion of SOP training and CGMP training.
• Ensure compliance with Good Manufacturing Practices (GMP and ISO), safety policies, and good housekeeping and that safety and hazard practices are understood and implemented.
• To analyse and solves engineering-related problems with effective manner.
• To work on lean management techniques to simplify the equipment qualification / validation approach.